FDAnews Device Daily Bulletin
Medical Devices / Regulatory Affairs

CDRH Exceeds 2017 Targets

Jan. 25, 2018

CDRH issued a new report describing how it exceeded its targets for 2017,

These include gaining access to 100 million electronic patient records by using device identification (result: 103 million records); an increase of 100 percent in the number of pre- and post-market regulatory decisions using real-world evidence (result: 193 percent); and engaging with 20 patient groups since 2016 (result: 48 patient groups).

Another 2017 target involved proposing a voluntary industry program aimed at improving product and manufacturing quality by year’s end. In December 2017, the center announced its plan to begin accepting applications for the voluntary Case for Quality Pilot Program by Jan. 2.

The program is aimed at identifying best practices and enhancing resource allocation for potential cost savings with the help of no more than nine enrolled participants.

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